510(k) Report

Devices descending from K020540

7 later devices reach Regenecare Wound Gel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092086Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model…Amerx Health Care Corp.20096—
+2K254191IWD-Gel™InnovaCorium, Inc.20260—
+2K211943Microlyte Ag/LidocaineImbed Biosciences20240—
+2K212521Field Shield Wound DressingKericure, Inc.20240—
+2K150792Next Science Wound GelNext Science, LLC20152—
+3K163188Next Science Wound Gel (Rx)Next Science, LLC20171—
+4K252028LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd.20260—